EN ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
This International Standard specifies general requirements for the characterization of a sterilizingagent and for the development, validation and routine monitoring and control of a sterilization process formedical devices.1.1.2This International Standard applies to sterilization processes in which microorganisms are inactivatedby physical and/or chemical means.1.1.3This International Standard is intended to be applied by process developers, manufacturers ofsterilization equipment, manufacturers of medical devices to be sterilized, and organizations responsible forsterilizing medical devices.1.1.4This International Standard specifies the elements of a Quality Management System which arenecessary to assure the appropriate characterization of the sterilizing agent, development, validation androutine monitoring and control of a sterilization process.
EN ISO 14937:2009 Referenced Document
ISO 10012 Measurement management systems - Requirements for measurement processes and measuring equipment
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements
ISO 11140-1 Sterilization of health care products - Chemical indicators - Part 1: General requirements
ISO 11737-1 Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1
ISO 11737-2 Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
EN ISO 14937:2009 history
2009EN ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
2000EN ISO 14937:2000 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices Incorporating Corrigendum December 2003 and March